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Can Protected Carotid Artery Stenting Replace Surgical Endarterectomy?
Susan C. Fagan, Pharm.D., BCPS, FCCP
Review: Yadav JS, Wholey MH, Kuntz RE, Fayad P, Katzen BT, Mishkel GJ, Bajwa TK, Whitlow P, Strickman NE, Jaff MR, Popma JJ, Snead DB, Cutlip DE, Firth BG, Ouriel K. Protected carotid-artery stenting versus endarterectomy in high-risk patients. N Engl J Med 2004;351:1493-1501.
The results of the SAPPHIRE trial were recently reported in N Engl J Med. This was an investigation comparing carotid endarterectomy (CEA) to carotid stenting and angioplasty with emboli protection in 334 patients who were at higher risk of complications from CEA than the patients that were included in the landmark trials (NASCET1 and ACAS2) supporting the safety and efficacy of CEA in patients with extracranial stenosis. Although stenting is used routinely in the care of coronary patients, the adoption of stenting in carotid artery disease has been slower because of technical difficulties with the procedure and the risk of embolization during the procedure. In this study, performed in 29 centers in the US, the primary endpoint was death, stroke or MI within 30 days or death or stroke between 31 days and 1 year after the procedure. Secondary endpoints included revascularization of the target vessel within 1 year.
The patients who had stenting had a lower risk of the primary endpoint (20 vs. 32), which was highly significant for noninferiority (p=0.004) and did not quite achieve significance for superiority (p=0.053). The increased incidence of occurrence of the primary endpoint in the CEA group was almost all accounted for by an increased 30 day MI rate in this group.
As expected, the stented group did not develop cranial nerve palsies and had shorter lengths of hospital stay (by one day).
The results of this study are good news for patients with cerebrovascular disease in that it is convincing that the technology for stenting in the cerebrovasculature is finally at the point where the procedure is safe and effective and definitely less invasive than CEA. Stenting is still not in a position to replace CEA as a first line intervention because of the small sample size and limited follow up time in this study (1 year). Investigators in the field expect this therapy to continue to evolve and improve as a viable way to prevent strokes in patients with extracranial stenosis. It even offers hope that intracranial stenosis may eventually be safely treated in this same manner, since the efficacy of antiplatelet and anticoagulant therapy still leave much room for improvement in the reduction of stroke in this group (WASID3).
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2. Executive Committee for the Asymptomatic Carotid Atherosclerosis Study. Endarterectomy for asymptomatic carotid artery stenosis. JAMA. 1995;273:1421-1428.
3. Chimowitz MI, Kokkinos J, Strong J, Brown MB, Levine SR, Silliman S, Pessin MS, Weichel E, Sila CA, Furlan AJ.The Warfarin-Aspirin Symptomatic Intracranial Disease Study. Neurology. 1995 Aug;45(8):1488-93.
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